SRC stands apart from all other pharmaceutical services companies in that we are perhaps the only one in India to have not only successfully conducted a PK end point study in aqueous humor within a short time-span but also successfully demonstrated our ability in developing and validating the bioanalytical method required for the study (Source: Clinical Trial Registry of India). This deep knowledge and expertise has made SRC the preferred ophthalmic drug development partner for a number of ophthalmic pharmaceutical companies in the US and in India.

Clinical sites in India have limited experience in the conduct of ophthalmic studies with PK endpoints, and hence identification and qualification of sites require a keen understanding of the institution’s capabilities and infrastructure. Based on our prior experience in conducting such studies, we have developed a robust approach to dealing with the associated challenges and training requirements for conducting such studies successfully. Some of the key measures taken are as follows:

Hands-on training of investigators and site personnel on accurate dosing using micropipette

Live demonstration of sample collection technique that avoids blinking of the eye

Certification by SRC bio-analytical expert of all key study personnel in dosing and sample collection prior to start of study

The pivotal bioequivalence studies for such ophthalmic products usually involve very large sample sizes (>500). Obtaining regulatory approval in India for conduct of such large PK studies with 100% of the patients to be recruited from India can be quite challenging. SRC has been successful in obtaining the approval for the first such study in India, which involved frequent meetings and discussions with the regulatory authorities on the clinical, scientific, statistical and ethical rationale for the study design and plan. SRC is therefore well poised to preempt and address any query that the DCGI may have during the review. Over the past few studies, SRC has also gathered valuable experience in understanding the recruitment challenges at the sites for such studies and executing the study with consistency, quality, while meeting all regulatory requirements.